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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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2011 Warning Letters

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Warning Letters issued in 2011

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

 
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Letter Issue Date Company Name Issuing Office Subject Close Out Date
11/21/2011 Dutch Valley Food Development Inc. [ARCHIVED] Philadelphia District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 04/05/2012
11/18/2011 Sandoz Incorporated [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated 07/16/2014
11/18/2011 Novartis International AG [ARCHIVED] Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated 07/16/2014
11/18/2011 Osmed GmbH [ARCHIVED] Center for Devices and Radiological Health Device Adulterated/Misbranded Not Issued *
11/18/2011 Global Sweet Polyols, LLC [ARCHIVED] New England District Office CGMP Regulations For Dietary Supplement/Adulterated Not Issued *
11/17/2011 Crescendo Therapeutics LLC [ARCHIVED] Los Angeles District Office Post-Marketing Adverse Drug Experience (PADE) Not Issued *
11/17/2011 B A Howie Inc. [ARCHIVED] New Jersey District Office CGMP for Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 11/02/2012
11/16/2011 Ming's Food, Inc. [ARCHIVED] Atlanta District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
11/16/2011 Innotech USA, Inc [ARCHIVED] Center for Devices and Radiological Health Electronic Product Radiation Control Not Issued *
11/16/2011 WellnessOne World, LLC [ARCHIVED] Minneapolis District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 06/21/2012
11/16/2011 Akzo Nobel Chemicals, S.A. de C.V. [ARCHIVED] Center for Drug Evaluation and Research CGMP for Finished Pharmaceuticals/Adulterated 06/11/2012
11/16/2011 Rose Stone Enterprises dba Hub Pharmaceuticals LLC [ARCHIVED] Los Angeles District Office Unapproved New Drugs/Misbranded Not Issued *
11/16/2011 Focus Laboratories, Inc [ARCHIVED] Dallas District Office Unapproved New Drugs/Misbranded Not Issued *
11/16/2011 Altaire Pharmaceuticals, Inc. [ARCHIVED] New York District Office Unapproved New Drugs/Misbranded 05/29/2012
11/16/2011 Sparboe Farms / Prairie Complex [ARCHIVED] Minneapolis District Office PHS Act/Shell Egg Regulation/Adulterated 08/19/2013
11/16/2011 Alexia Foods, Inc [ARCHIVED] Center for Food Safety and Applied Nutrition Food Labeling/Misbranded Not Issued *
11/16/2011 Aranda's Pickled Mushrooms, LLC [ARCHIVED] Minneapolis District Office Acidified Foods/Adulterated Not Issued *
11/15/2011 Xylo Chem Industries [ARCHIVED] Center for Drug Evaluation and Research CGMP/Finished Pharmaceuticals/Adulterated Not Issued *
11/15/2011 Rojas, Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated/Misbranded Not Issued *
11/15/2011 Reiland, James M. [ARCHIVED] Minneapolis District Office Illegal Drug Residue 12/19/2011
11/15/2011 Humpty Dumpty Eggs, Inc [ARCHIVED] Minneapolis District Office PHS Act/Shell Egg Regulation/Adulterated 07/30/2012
11/14/2011 Maria Santana Aviles Los Angeles District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/10/2011 Golden Temple of Oregon, LLC - Tea Facility [ARCHIVED] Seattle District Office CGMP for Dietary Supplements/New Drug Claims 07/31/2012
11/10/2011 RMO, Inc. [ARCHIVED] Denver District Office CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated 06/08/2012
11/10/2011 Great Oceans, LLC [ARCHIVED] New York District Office Seafood HACCP/Adulterated 05/06/2015
11/10/2011 Tonka Seafoods, Inc. [ARCHIVED] Seattle District Office Low Acid Canned Food Regulation/Adulterated Not Issued *
11/10/2011 The Sandwich Man, Inc. [ARCHIVED] New Orleans District Office CGMP Regulation For Food/Adulterated/Misbranded Not Issued *
11/09/2011 Ocean Group Inc. (dba Ocean Fresh Fish & Seafood Marketing) [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated 09/17/2012
11/08/2011 Greenville Loop Seafood, Inc. [ARCHIVED] Atlanta District Office CGMP Regulation For Food/Adulterated Not Issued *
11/08/2011 Lakeland Bakery, Inc. [ARCHIVED] Minneapolis District Office Food Labeling/Misbranded 09/18/2012
11/08/2011 Country Maid, Inc. [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions 04/12/2013
11/07/2011 Son-D-Farms Inc [ARCHIVED] Minneapolis District Office Illegal Drug Residue 01/23/2012
11/07/2011 Dongguan Dalang Vigor Electronics Mfy. [ARCHIVED] Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/07/2011 Silver Moon Springs LLC [ARCHIVED] Minneapolis District Office Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Not Issued *
11/07/2011 Blue Water Connection Seafood Corp. [ARCHIVED] Florida District Office CGMP for Foods/Seafood HACCP/Adulterated Not Issued *
11/04/2011 Diaz, Leslie, M.D. [ARCHIVED] Center for Drug Evaluation and Research Clinical Investigator Not Issued *
11/03/2011 Tan Hung Bakery [ARCHIVED] San Francisco District Office Labeling/False & Misleading Claims/Misbranded 08/06/2012
11/01/2011 Beckman Coulter, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated 01/21/2014
11/01/2011 Rainbow LTD, Inc. dba PN Medical [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated Not Issued *
11/01/2011 CJ Labs, Inc. [ARCHIVED] Florida District Office CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements/Adulterated Not Issued *
11/01/2011 Frank L Harter & Sons Inc [ARCHIVED] Cincinnati District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
11/01/2011 Pace Tech, Inc. [ARCHIVED] Florida District Office CGMP/QSR/Medical Devices/Adulterated/Misbranded Not Issued *
10/31/2011 Global Bakery Corporation [ARCHIVED] San Juan District Office Food Labeling 07/12/2012
10/31/2011 Pt. Bitung Mina Utama [ARCHIVED] Center for Food Safety and Applied Nutrition Seafood HACCP/Adulterated Not Issued *
10/31/2011 AD and AD International, Ltd. [ARCHIVED] Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
10/31/2011 IndoCigs [ARCHIVED] Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Not Issued *
10/28/2011 Alabama Sunshine, Inc. [ARCHIVED] New Orleans District Office CGMP/Acidified Foods/Adulterated 08/04/2014
10/28/2011 Wrapers Kitchen [ARCHIVED] Denver District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
10/28/2011 Hayai Zushi [ARCHIVED] Denver District Office Seafood HACCP/CGMP for Foods/Adulterated Not Issued *
10/27/2011 Seven Seas Seafoods Inc. [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated Not Issued *

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